FDA Announces New Draft Guidance to Streamline Development of Biosimilars

The FDA has announced another “major step” in its initiative to “streamline the development of biosimilar medicines.”

The agency has recommended “streamlining unnecessary clinical pharmacokinetic (PK) testing when scientifically justified. This change could save biosimilar developers up to 50% of their PK study costs, or approximately $20 million, and help lower drug costs.”

Biologic medicines offer treatment for severe diseases but are “often expensive.” They account for 51% of drug spending despite representing only 5% of all prescriptions. Biosimilars can “give patients more affordable treatment options and increase access to medications that are otherwise unaffordable.” This announcement builds on draft guidance from October meant to “reduce unnecessary comparative efficacy studies.”

This new draft guidance is “intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars.” It revises draft guidance published in 2021. Specifically, the guidance “provides updated recommendations to prospective biosimilar applicants seeking to use data from a comparator product approved outside the U.S. (“non-U.S.-licensed comparator product”) as evidence that a proposed product is biosimilar to the U.S.-licensed product.”